Medical devices are grouped into classes based on risk. Lower-risk devices generally face lighter requirements; higher-risk devices need more evidence and closer review.
Your device class affects the testing you need, the quality system expected of you and how long approval may take. It is worth confirming the class early, before you plan budgets and timelines.
Classification depends on factors such as intended use, duration of contact with the body and whether the device is active or implantable. Small changes to the intended use statement can change the class.
If you are unsure, discuss your device with a regulatory expert at the concept stage. Getting this right early prevents rework later.
